Phase I/II Study of the Combination of Irinotecan and POF (POFI) and Tislelizumab
ConditionGastric Cancer Stage IV
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFujian Cancer Hospital
About this trial
The purpose of the phase I/II study is to establish the safety of Combination of Irinotecan and paclitaxel with 5-FU, leucovorin, oxaliplatin and Tislelizumab.
Eligibility criteria
Qualifiers
Patients with advanced unresectable, histologically confirmed adenocarcinoma of the gastric or gastroesophageal junction.
With or without measurable lesions.
Patients must have a performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale.
Without serious system dysfunction and could tolerate chemotherapy. With normal marrow, liver and renal function: a hemoglobin (HGB) of ≥100g/L (without blood transfusion during 14 days); a leucopenia count of ≥4.0×109/L; a platelet count of ≥100×109/L; a total bilirubin (TBil) of ≤1.5 upper normal limitation (UNL); a creatinine (Cr) of ≤ 1.5 UNL; a creatinine clearance rate ≥ 50ml/min (Cockcroft-Gault); a alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) of ≤2.5 UNL or ≤5 UNL in case of liver metastasis.
Disqualifiers
Patients with a history of another neoplastic disease within the past three years, excluding basal cell carcinoma of the skin, cervical carcinoma in situ, or nonmetastatic prostate cancer.
Patients with brain or central nervous system metastases, including leptomeningeal disease.
Pregnant (positive pregnancy test) or breast feeding.
Serious, non-healing wound, ulcer, or bone fracture.
Trial design
Treatments tested in this trial
- Oxaliplatin
- Levo-Leucovorin
- 5-fluorouracil
- Paclitaxel
- Irinotecan
- Tislelizumab
Treatment groups
51 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov